For detailed information on all aspects of CLIA, please refer to the CLIA website

Q. How do I apply for a CLIA certificate?

• Download the application and instructions from the CLIA website:
  • Go to the first option on the left side: "How to apply for a CLIA certificate, including International Laboratories Program".
  • E-Mail completed application to: CLIA.Delaware@delaware.gov
  • Please do not include the instructions, email only the first five pages.

Q. How do I determine what type of CLIA certificate to apply for?

• The CMS-116 form includes 5 pages of instructions. This information can be found on the first page of instructions for completing the CLIA application form, CMS-116.

Q. How do I determine the test complexity of a particular test?

• On the CLIA website, select the fourth option on the left side pick list: "Categorization of Tests". Near the bottom of the page, you will find "Related Links" which will link to "Test Complexity Database – All Complexities (FDA) Site".

Q. Should I send a check with my CLIA application?

• No. Bills are generated by a separate lockbox.

Q. After I submit a CLIA application, how long does it take to get the certificate?

• A completed CLIA application is entered into a special data system. A lockbox generates a bill which you will receive within one to two weeks. Once your payment is received (you may send it online to the CLIA Website), it will take another one to two weeks to receive your certificate. Total processing takes approximately two to four weeks.

Q. In what instances can I get a replacement certificate?

Replacement certificates may be obtained in the following instances:

• Director change.
• Facility name change.
• Change in location and /or mailing address.
• Certificate never arrived.
• Certificate lost.
• Note: All changes must be submitted in writing to the State of Delaware CLIA address above. Be sure to include your CLIA ID number and the following information: facility name, address, lab director and the information you want changed. Must be signed by a person authorized to make changes.

Q. How long does it take to get a replacement certificate?

• It takes approximately one to two weeks to receive a replacement certificate. After the Delaware State CLIA Surveyor receives your request, it is submitted to the Baltimore for processing.

Q. Medicare is denying my claim(s), stating I don’t have the correct CLIA certification. What should I do?

• Often, this has nothing to do with the type of CLIA certificate you have. This problem usually occurs when there has been a change in the CPT code or if the CPT code needs a QW added to it. Another common reason for claim denial is the certificate is expired or incorrect. To check your certificate, go to the website above and click on the 12th item, "Laboratory Demographics Look up". Click on the link, please see "S&C's Quality, Certification and Oversight Reports (QCOR)". Click "ok" on the box that pops up. Then click on "CLIA Laboratory Lookup". You need only to enter your CLIA number including the "D" Click on "Search".

Q. I am in the process of reviewing our protocol and wanted to ensure we are meeting the requirements set out by the State of Delaware. Our screenings involve a finger stick blood test (utilizing the Cholestech machine, a CLIA waived test), blood pressure and height/weight. We currently maintain our CLIA wavier; however, I was writing to inquire if there is any other paperwork or procedures required within your State.

• The State of Delaware only follows CLIA guidelines. There are no additional requirements unique to Delaware.

Q. How do I file a complaint?

A complaint may be submitted:

• By phone or in writing to the State of Delaware CLIA Program, Delaware Public Health Laboratory.
• By E-mail to: CLIA.Delaware@delaware.gov

Q. What is the State of Delaware's policy on Direct Access Testing?

• At this time, Delaware allows Direct Access Testing with no limitations; however, individual laboratories within the state may have their own restrictive guidelines.

This page was last updated 12/2023

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